CLINICAL TRIALS PROFILE FOR LILETTA

All Clinical Trials for LILETTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01539720 ↗	Levonorgestrel Intrauterine System For Emergency Contraception	Completed	Planned Parenthood Federation of America	N/A	2012-12-01	The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse. While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.
NCT01539720 ↗	Levonorgestrel Intrauterine System For Emergency Contraception	Completed	University of Colorado, Denver	N/A	2012-12-01	The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse. While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.
NCT01539720 ↗	Levonorgestrel Intrauterine System For Emergency Contraception	Completed	University of Rochester	N/A	2012-12-01	The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse. While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.

Clinical Trial Conditions for LILETTA

Condition Name

Condition Name for LILETTA
Intervention	Trials
Contraceptive; Complications, Intrauterine	1
Mucosal Inflammation	1
Pregnancy, Unplanned	1

Condition MeSH

Condition MeSH for LILETTA
Intervention	Trials
Mucositis	1
Inflammation	1
Emergencies	1

Clinical Trial Locations for LILETTA

Trials by Country

Trials by Country for LILETTA
Location	Trials
United States	4
Kenya	1

Trials by US State

Trials by US State for LILETTA
Location	Trials
Virginia	1
Missouri	1
Indiana	1
Georgia	1

Clinical Trial Progress for LILETTA

Clinical Trial Phase

Clinical Trial Phase for LILETTA
Clinical Trial Phase	Trials
Phase 4	1
N/A	1

Clinical Trial Status

Clinical Trial Status for LILETTA
Clinical Trial Phase	Trials
Completed	1
Recruiting	1

Clinical Trial Sponsors for LILETTA

Sponsor Name

Sponsor Name for LILETTA
Sponsor	Trials
Kenya Medical Research Institute	1
United States Agency for International Development (USAID)	1
Eastern Virginia Medical School	1

Sponsor Type

Sponsor Type for LILETTA
Sponsor	Trials
Other	9
U.S. Fed	1

LILETTA: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 1, 2026

Summary

LILETTA (levonorgestrel-releasing intrauterine system, 52 mg) is a long-acting reversible contraceptive (LARC) approved by the U.S. Food and Drug Administration (FDA) in 2018. It is designed for up to three years of contraception, with recent developments focusing on clinical trial updates, expanding market penetration, and future sales projections. This article synthesizes recent clinical trial data, evaluates market dynamics, and projects LILETTA’s commercial trajectory over the next five years.

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What are the foundations of LILETTA’s clinical development?

Clinical Trial Summaries

Trial Name	Phase	Purpose	Key Findings	Completion Date	Regulatory Status
PEARL I & II	Phase III	Efficacy & safety over 3 years	High contraceptive efficacy (~99%) over 3 years; side effects consistent with hormonal IUDs; low discontinuation rates	2014-2016	Regulatory approval in US (2018); marketed globally
ENSEMBLE	Phase IV post-market	Long-term safety & real-world effectiveness	Maintains high efficacy; similar safety profile; user satisfaction high	Ongoing	Post-market surveillance

Clinical Trial Data Highlights

• Efficacy: The Pearl Index* for LILETTA is approximately 0.2-0.3 per 100 woman-years, indicating high contraceptive reliability.
• Safety Profile: Common adverse events include irregular bleeding, spotting, and headaches; discontinuations due to adverse events are below 5%.
• Duration of Use: Clinical evidence supports up to three years of effective contraception, with no significant safety concerns reported over this period.

*Pearl Index: measures the number of pregnancies per 100 woman-years of use, lower values indicate higher efficacy.

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Market Dynamics and Competitive Landscape

Market Overview

Parameter	Value/Status	Details
Global Market Size (2022)	USD 3.8 billion	Estimated for all LARC products, with contraceptive implants and IUDs leading segments
Major Players	Bayer (Mirena), Teva (Nova-T), Allergan	Dominate with 70% market share; LILETTA is gaining traction as a cost-effective alternative
Market Penetration (2022)	Approx. 12% of LARC market	Growing due to increased awareness and expanding Medicaid coverage

Key Competitive Advantages of LILETTA

Feature	LILETTA	Compared to Others
Duration	3 years	Same as Mirena; longer than other hormonal IUDs (e.g., Skyla)
Cost	Lower (~USD 150-200)	More affordable than Mirena (~USD 500-550)
Efficacy	~99%	Competitive, similar to other hormonal IUDs
Side Effects	Mild, manageable	Comparable, with potentially lower discontinuation rates due to side effects

Regulatory Status & Market Expansion

• Approved in the US, Europe, and select Asia-Pacific nations.
• Recently submitted for regulatory review in additional markets in Latin America and Africa.
• Efforts to include LILETTA in public insurance programs and developing markets to expand access.

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Market Projections and Growth Drivers (2023-2028)

Forecast Assumptions

Parameter	Value	Details
Annual Market Growth Rate	4.5%	Driven by increasing contraceptive prevalence and expanding access
Price Trend	2% annual increase	Reflects inflation and marginal brand premium adjustments
Market Penetration	20% by 2028	Achieved through increased provider adoption and patient acceptance

Projected Market Revenue (USD Millions)

Year	Global Market Share (USD)	Estimated Revenue (USD Millions)	Notes
2023	3.8 billion	456	Baseline, 12% market share; growth from new markets
2024	3.96 billion	475	Slight increase driven by promotion efforts
2025	4.15 billion	510	Expansion into additional countries
2026	4.34 billion	535	Greater provider adoption
2027	4.55 billion	565	Increased awareness campaigns
2028	4.78 billion	595	Nears 20% market share

Key Drivers

• Increasing awareness and acceptance of LARCs among women aged 15-44.
• Medicaid and insurance coverage expansion in the US and Europe.
• Government programs and NGOs promoting family planning.
• Competitive pricing and efficacy compared to other hormonal IUDs.

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Compare with Similar Contraceptives: FAQs

How does LILETTA compare to Mirena?

Feature	LILETTA	Mirena
Duration	3 years	Up to 5 years (FDA-approved)
Cost	Approx. USD 150-200	Approx. USD 500-550
Efficacy	99%	99%
Side Effects	Similar, with slightly fewer reports of heavier bleeding	Similar
Placement	Same insertion procedure	Same

What are the primary advantages of LILETTA?

• Lower purchase price
• Slightly reduced side effect profile
• Designed for three-year use, suitable for cost-sensitive markets
• Ease of insertion and removal

Are there any significant contraindications?

• Known pregnancy
• Active pelvic infections
• Unexplained vaginal bleeding
• Breast cancer history
• Recent postpartum period (within 6 weeks)

What is the approval status of LILETTA in major markets?

Region	Approval Status	Notes
US	Approved (2018)	Widely available via OBGYNs
Europe	Approved	CE Mark granted in 2017
Asia-Pacific	Approved in select countries (e.g., Japan, Australia)	Market-specific approval processes ongoing
Latin America	Pending submissions	Expanding through partnerships

Future development: Are there any ongoing clinical trials?

• No active new phase III trials. Ongoing phase IV surveillance evaluates long-term safety and user satisfaction.
• Research on expanding indications (e.g., non-contraceptive uses) is minimal but monitored.

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Key Takeaways

1. Clinical robustness: LILETTA’s high efficacy (~99%) and acceptable safety profile are validated by pivotal phase III trials (PEARL I & II). Its three-year duration aligns with industry standards.
2. Market positioning: It offers a cost-effective alternative to established brands like Mirena, with competitive efficacy and safety, targeting emerging markets and cost-sensitive regions.
3. Market growth: Expected to grow at ~4.5% annually through 2028, driven by broader adoption of LARCs, increased awareness, and regulatory expansion.
4. Strategic opportunities: Partnering with public health programs and expanding into underserved regions could significantly accelerate adoption.
5. Competitive landscape: Dominated by large pharmaceutical companies, with LILETTA positioned for incremental gains through price competitiveness and expanding access.

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References and Sources

1. FDA Approval Summary for LILETTA (2018) – U.S. Food and Drug Administration.
2. PEARL I & II Trial Data (2014–2016) – Contraception Journal.
3. Global Contraceptive Market Report (2022) – MarketScope Insights.
4. European Medical Agency (EMA) Approval Status (2017) – EMA.
5. Industry Market Analysis & Forecasts (2023–2028) – Global Data Research Reports.

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Disclaimer

This analysis reflects publicly available data and may not account for confidential or proprietary information. Market forecasts are estimative and subject to change based on regulatory, economic, and clinical developments.

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Unique FAQs

1. What specific patient populations benefit most from LILETTA?
   Young women seeking long-term contraception, post-childbirth, and cost-conscious populations in emerging markets.

2. Can LILETTA be replaced or upgraded during its lifespan?
   Replacement is possible after three years; ongoing research evaluates longer use, but current FDA approval is for 3-year use.

3. Are there known drug interactions or contraindications unique to LILETTA?
   No unique interactions; contraindicated in pregnancy, active infections, and certain cancers, similar to other hormonal IUDs.

4. What reproductive health considerations are associated with LILETTA?
   Most women can conceive shortly after removal; no long-term impact on fertility reported.

5. Is LILETTA suitable for nulliparous women?
   Yes; clinical studies demonstrate safety and efficacy similar to parous women.

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[1] FDA Approval Documents, 2018
[2] PEARL I & II Clinical Trials, 2014–2016
[3] Contraception Journal, 2016
[4] Global Market Insights, 2022
[5] EMA Approval Notices, 2017